Trial Outcomes & Findings for Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS) (NCT NCT00472290)

NCT ID: NCT00472290

Last Updated: 2017-12-29

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks .
• Results posted on: 2017-12-29

Participant Flow

This study was available to subjects who completed a previous romiplostim study for the treatment of thrombocytopenia in subjects with low or intermediate-1 risk MDS. First Subject Enrolled: 17-Jul-2007; Last Subject Enrolled: 15-Feb-2011

Participant milestones

Measure	Romiplostim Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
Overall Study STARTED	72
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	72

Reasons for withdrawal

Measure	Romiplostim Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
Overall Study Progression of Therapy-Related MDS	1
Overall Study Protocol Specified Criteria	7
Overall Study Administrative Decision	37
Overall Study Death	3
Overall Study Lost to Follow-up	1
Overall Study Lack of Efficacy	1
Overall Study Disease Progression	4
Overall Study Withdrawal by Subject	5
Overall Study Adverse Event	6
Overall Study Requirement for alternative therapy	7

Baseline Characteristics

Evaluating the Safety of Long Term Dosing of Romiplostim (Formerly AMG 531) in Thrombocytopenic Subjects With Myelodysplastic Syndromes (MDS)

Baseline characteristics by cohort

Measure	Romiplostim n=72 Participants Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
Age, Continuous	68.9 Years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	32 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Race/Ethnicity, Customized White or Caucasian	61 Participant n=5 Participants
Race/Ethnicity, Customized Black or African American	4 Participant n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participant n=5 Participants
Race/Ethnicity, Customized Other	4 Participant n=5 Participants
Myelodysplastic Syndromes World Health Organization Classification at Study Screening RA: Refractory Anemia	20 Participants n=5 Participants
Myelodysplastic Syndromes World Health Organization Classification at Study Screening RARS: Refractory Anemia with Ringed Sideroblasts	1 Participants n=5 Participants
Myelodysplastic Syndromes World Health Organization Classification at Study Screening RAEB-1: Refractory Anemia with Excess Blasts-1	7 Participants n=5 Participants
Myelodysplastic Syndromes World Health Organization Classification at Study Screening RAEB-2: Refractory Anemia with Excess Blasts-2	2 Participants n=5 Participants
Myelodysplastic Syndromes World Health Organization Classification at Study Screening RCMD:Refractory cytopenia w multilineage dysplasia	24 Participants n=5 Participants
Myelodysplastic Syndromes World Health Organization Classification at Study Screening RCMD-RS: RCMD and ringed sideroblasts	3 Participants n=5 Participants
Myelodysplastic Syndromes World Health Organization Classification at Study Screening MDS-U: Myelodysplastic syndrome - unclassified	15 Participants n=5 Participants
Myelodysplastic Syndromes World Health Organization Classification at Study Screening MDS associated with isolated del(5q)	0 Participants n=5 Participants
Eastern Cooperative Oncology (ECOG) performance status 0: Fully active	42 Participants n=5 Participants
Eastern Cooperative Oncology (ECOG) performance status 1: Can carry out light or sedentary work	25 Participants n=5 Participants
Eastern Cooperative Oncology (ECOG) performance status 2: Capable of selfcare but unable to work	5 Participants n=5 Participants
Eastern Cooperative Oncology (ECOG) performance status >=3: Capable of only limited selfcare or worse	0 Participants n=5 Participants
Baseline Platelet Count	27.6 10^9/L STANDARD_DEVIATION 15.5 • n=5 Participants

PRIMARY outcome

Timeframe: During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks .

Population: Safety analysis includes subjects who took at least one dose of romiplostim.

Outcome measures

Measure	Romiplostim n=72 Participants Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
Overall Summary of Adverse Events Subjects Reporting Any AE	71 Participant
Overall Summary of Adverse Events Subjects Reporting Any Treatment-related AE	19 Participant
Overall Summary of Adverse Events Subjects Reporting Any Treat-related Serious AE	4 Participant
Overall Summary of Adverse Events Subjects Reporting Any Serious AE	29 Participant
Overall Summary of Adverse Events Subjects Withdrew Study or Stop IP Due to AE	8 Participant

PRIMARY outcome

Timeframe: During treatment period from first dose of IP to End of Study visit, on Average 56 Weeks.

Population: Safety analysis includes subjects who took at least one dose of romiplostim.

Outcome measures

Measure	Romiplostim n=72 Participants Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
Incidence of Antibody (AB) Formation Positive binding AB to IP at or before baseline	5 Participant 94.7
Incidence of Antibody (AB) Formation Neutralizing AB to IP at or before baseline	0 Participant
Incidence of Antibody (AB) Formation Binding AB positive to IP post-baseline only	5 Participant
Incidence of Antibody (AB) Formation Persistent binding AB positive to IP	4 Participant
Incidence of Antibody (AB) Formation Transient binding AB positive to IP	1 Participant
Incidence of Antibody (AB) Formation Positive binding AB to TPO at or before baseline	4 Participant
Incidence of Antibody (AB) Formation Neutralizing AB to TPO at or before baseline	0 Participant
Incidence of Antibody (AB) Formation Binding AB positive to TPO post-baseline only	3 Participant
Incidence of Antibody (AB) Formation Persistent binding AB positive to TPO	2 Participant
Incidence of Antibody (AB) Formation Transient binding AB positive to TPO	1 Participant

SECONDARY outcome

Timeframe: During the treatment period. The average duration of romiplostim exposure is 56 weeks.

Population: Safety analysis includes subjects who received at least one dose of romiplostim.

During the time since the first dose of IP to the end of the treatment period. A single bleeding event was defined as each individual bleeding episode that originated from a specific organ system (eg, gastrointestinal system or central nervous system). A bleeding event that continued for more than 7 days was counted as separate events every eighth day.

Outcome measures

Measure	Romiplostim n=866 Events Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
Weekly Bleeding Events Per 100 Subject Years	1120.5 Events/100 subject-year Interval 1047.1 to 1197.7

SECONDARY outcome

Timeframe: During the treatment period. The average duration of romiplostim exposure is 56 weeks.

Population: Safety analysis includes subjects who received at least one dose of romiplostim.

During the time since the first dose of IP to the end of the treatment period. A discrete platelet transfusion event was defined as any number of platelet transfusions administered within a 3-day period. Platelet transfusions administered more than 3 days apart were counted as separate platelet transfusion events.

Outcome measures

Measure	Romiplostim n=158 Events Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
Platelet Transfusion Events Per 100 Subject Years	204.4 Events/100 subject-year Interval 173.8 to 238.9

SECONDARY outcome

Timeframe: During the treatment period. The average duration of romiplostim exposure is 56 weeks.

Population: Safety analysis includes subjects who received at least one dose of romiplostim.

During the time since the first dose of IP to the end of the treatment period. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.

Outcome measures

Measure	Romiplostim n=2675 Weeks with Platelet Response Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
Weeks With Platelet Response Per Year	34.6 Weeks/Subject-year Interval 33.3 to 35.9

SECONDARY outcome

Timeframe: During treatment period. The average duration of romiplostim exposure is 56 weeks.

Population: Safety analysis includes subjects who received at least one dose of romiplostim.

Time since first dose of IP to the first platelet response. Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.

Outcome measures

Measure	Romiplostim n=2675 Weeks with Platelet Response Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
Time to First Platelet Response	2.3 Weeks Interval 2.1 to 3.1

SECONDARY outcome

Timeframe: During treatment period. The average duration of romiplostim exposure is 56 weeks.

Population: Safety analysis includes subjects who received at least one dose of romiplostim.

Platelet response was based on the modified IWG 2006 criteria (Cheson et al, 2006) and was defined as, in the absence of platelet transfusion: an absolute increase in platelet count of ≥ 30 x 10^9/L for a subject starting with a platelet count of ≥ 20 x 10^9/L; or an increase in platelet count from < 20 x 10^9/L to ≥ 20 x 10^9/L and by at least 100% in a subject that started with a platelet count < 20 x 10^9/L.

Outcome measures

Measure	Romiplostim n=2675 Weeks with Platelet Response Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
Duration of Platelet Response	20.0 Weeks Full Range 49.5 • Interval 1.0 to 159.0

Adverse Events

Romiplostim

Serious events: 29 serious events

Other events: 66 other events

Deaths: 0 deaths

Serious adverse events

Measure	Romiplostim n=72 participants at risk
Blood and lymphatic system disorders Anaemia	2.8% 2/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Febrile neutropenia	2.8% 2/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Lymphadenopathy	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Pancytopenia	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac arrest	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure congestive	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Coronary artery disease	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Myocardial infarction	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Tachycardia	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Congenital, familial and genetic disorders Muscular dystrophy	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Colitis	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrointestinal haemorrhage	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal obstruction	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Intestinal perforation	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Mouth haemorrhage	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Small intestinal obstruction	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Varices oesophageal	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest pain	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bacteraemia	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchitis	2.8% 2/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diverticulitis	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Fungaemia	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lobar pneumonia	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Lung infection	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	4.2% 3/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	2.8% 2/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Fall	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Spinal compression fracture	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood creatinine increased	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	2.8% 2/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Osteonecrosis	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell lymphoma	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myeloid leukaemia	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B-cell lymphoma	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral haemorrhage	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebral ischaemia	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Depressed level of consciousness	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Haemorrhage intracranial	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hepatic encephalopathy	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hypoaesthesia	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Speech disorder	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Anxiety	2.8% 2/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Depression	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Suicidal ideation	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Haematuria	2.8% 2/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure acute	2.8% 2/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Endometrial hypertrophy	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary fibrosis	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary hilum mass	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary vascular disorder	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin lesion	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Haematoma	4.2% 3/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Phlebitis	1.4% 1/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Measure	Romiplostim n=72 participants at risk
Blood and lymphatic system disorders Anaemia	18.1% 13/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	6.9% 5/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Palpitations	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Eye haemorrhage	9.7% 7/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	16.7% 12/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	15.3% 11/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	11.1% 8/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gingival bleeding	11.1% 8/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Haemorrhoids	8.3% 6/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Mouth haemorrhage	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	8.3% 6/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Toothache	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	11.1% 8/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	8.3% 6/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	20.8% 15/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	6.9% 5/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pain	8.3% 6/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	12.5% 9/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Bronchitis	6.9% 5/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nasopharyngitis	9.7% 7/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	12.5% 9/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	8.3% 6/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Contusion	16.7% 12/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Laceration	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Weight decreased	6.9% 5/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Decreased appetite	8.3% 6/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	19.4% 14/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	12.5% 9/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	6.9% 5/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Myalgia	6.9% 5/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Neck pain	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	8.3% 6/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dizziness	9.7% 7/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	15.3% 11/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Depression	6.9% 5/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Insomnia	6.9% 5/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	23.6% 17/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	9.7% 7/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	31.9% 23/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Blood blister	8.3% 6/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Ecchymosis	11.1% 8/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Petechiae	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Pruritus	8.3% 6/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Haematoma	15.3% 11/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertension	5.6% 4/72 • The average duration is 56 weeks The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

• Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial resul
• Publication restrictions are in place

Restriction type: OTHER